BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3121768 · Received May 10, 2013

    Report

    Report Number
    3003640913-2013-00021
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD STAR SLIDING CORE BEARING COMPONENT REVISED AFTER 12 YEARS OF IMPLANTATION. VISUAL EVALUATION CONFIRMED POLY WAS FRACTURED. DEVICE HISTORY RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PATIENT HAD STAR SLIDING CORE BEARING COMPONENT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205438 STAR TOTAL ANKLE REPLACEMENT STAR SLIDING CORE COMPONENT HSN SMALL BONE INNOVATIONS, INC. 400-140 0042074

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXOSTEOTOMY OF MEDIAL AND LATERAL GUTTERS